Interspinous process implant and fusion cage spacer

ABSTRACT

A spinal implant includes an elongated body dimensioned and configured to function as a spacer, for placement in a target interspinous process space, between two adjacent spinous processes, a distal anchor associated with a distal end of the body, and a proximal anchor mounted for longitudinal movement along the body between a first position spaced apart from the head and a second position approximated with the head, adapted to compress the two adjacent spinous processes, in conjunction with the distal anchor.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/560,006 filed Dec. 4, 2014, which is a continuation of U.S. patentapplication Ser. No. 12/554,922, filed Sep. 7, 2009, now U.S. Pat. No.8,945,184, which claims the benefit of and priority to U.S. ProvisionalPatent Application Ser. No. 61/209,997, filed Mar. 13, 2009, theseapplication are incorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The subject invention is directed to spinal implants, and moreparticularly, to an interspinous process implant for spinalstabilization, for percutaneous placement in a target interspinousprocess space, which can also serve as a fusion cage spacer to treatlumbar spinal stenosis.

2. Description of Related Art

The spine consists of a column of twenty-four vertebrae that extend fromthe skull to the hips. Discs of soft tissue are disposed betweenadjacent vertebrae. The vertebrae provide support for the head and body,while the discs act as cushions. In addition, the spine encloses andprotects the spinal cord, defining a bony channel around the spinalcord, called the spinal canal. There is normally a space between thespinal cord and the borders of the spinal canal so that the spinal cordand the nerves associated therewith are not pinched.

Over time, the ligaments and bone that surround the spinal canal canthicken and harden, resulting in a narrowing of the spinal canal andcompression of the spinal cord or nerve roots. This condition is calledspinal stenosis, which results in pain and numbness in the back andlegs, weakness and/or a loss of balance. These symptoms often increaseafter walking or standing for a period of time.

There are number of non-surgical treatments for spinal stenosis. Theseinclude non-steroidal anti-inflammatory drugs to reduce the swelling andpain, and corticosteroid injections to reduce swelling and treat acutepain. While some patients may experience relief from symptoms of spinalstenosis with such treatments, many do not, and thus turn to surgicaltreatment. The most common surgical procedure for treating spinalstenosis is decompressive laminectomy, which involves removal of partsof the vertebrae. The goal of the procedure is to relieve pressure onthe spinal cord and nerves by increasing the area of the spinal canal.

Interspinous process decompression (IPD) is a less invasive surgicalprocedure for treating spinal stenosis. With IPD surgery, there is noremoval of bone or soft tissue. Instead, an implant or spacer device ispositioned behind the spinal cord or nerves between the interspinousprocesses that protrude from the vertebrae in the lower back. Awell-known implant used for performing IPD surgery is the X-STOP®device, which is described in U.S. Pat. No. 6,419,676, the disclosure ofwhich is herein incorporated by reference in its entirety. However,implantation of the X-STOP® device still requires an incision to accessthe spinal column to deploy the X-STOP® device.

An interspinous process implant placed in a minimally invasive surgicalprocedure is disclosed in U.S. Patent Application Publication2008/0243250, which is also incorporated herein by reference in itsentirety. This implant functions as a spacer between two adjacentspinous processes, but it is not designed to stabilize the spinousprocess and can migrate over time.

It would be advantageous to provide an implant for performing IPDprocedures that can be percutaneously inserted into the interspinousprocess space to effectively treat lumbar spinal stenosis bydistracting, or maintaining distraction, and sufficiently stabilizingadjacent spinous processes, and thus, adjacent vertebrae.

SUMMARY OF THE INVENTION

In accordance with one aspect, the invention is directed to a spinalimplant having an elongated body dimensioned and configured to functionas a spacer, for placement in a target interspinous process space,between two adjacent spinous processes, a distal anchor associated witha distal end of the body, and a proximal anchor mounted for longitudinalmovement along the body between a first position spaced apart from thehead and a second position approximated with the head, adapted tocompress the two adjacent spinous processes, in conjunction with thedistal anchor.

The proximal anchor can include an axially slideable plate.

The elongated body can be provided with threads at least on a distalportion thereof for facilitating engagement with bony anatomicalstructures.

The proximal anchor can include a plurality of circumferentially spacedapart distally facing spikes for engaging the spinous processes when thedistal anchor and the proximal anchor are approximated.

The body and proximal anchor can be threadedly associated with oneanother to facilitate longitudinal movement of the proximal anchor alongthe body between the first and second positions.

The body can be at least partially hollow and include a plurality ofopenings for permitting tissue ingrowth.

The body can be provided with a tapered head portion, configured togradually distract the two adjacent spinous processes during insertiontherebetween. Similarly, the shape of the body can ease insertion of theimplant in-between the adjacent spinous processes after distractionthereof by a separate instrument or instruments.

The distal anchor can include a plurality of radially-deployable bladesadapted for engaging adjacent spinous processes. The body can beprovided with an internal chamber in which the plurality ofradially-deployable blades are stowed prior to deployment thereof. Theplurality of radially-deployable blades can be hinged by a commonannular pivot member. Alternatively, the plurality ofradially-deployable blades can be hinged by a common linear pivotmember. The spinal implant can further include an internal plungeradapted for deploying the plurality of radially-deployable blades, byway of a camming mechanism.

In accordance with the invention, the distal anchor can be provided ineither a normally expanded or otherwise deployed condition, oralternatively, in a normally contracted or otherwise stowed condition.The term “normally” means that the implant, absent externally-appliedforces, maintains that condition.

The distal anchor can include a tapered head, wherein the tapered headhas a maximum diameter that is, in its neutral state, greater than adiameter of the elongated body. The tapered head can have a plurality ofcircumferentially spaced apart proximally-facing spikes for engaging thespinous processes when the head and the anchor are approximated. Thetapered head can have a trailing skirt section adapted and configuredfor movement between a radially expanded condition and a radiallycompressed condition as the head is inserted between the two adjacentspinous processes. The trailing skirt section of the head can include aplurality of circumferentially spaced apart hinged pleats that arebiased into the radially expanded condition. Alternatively, these pleatscan be biased in a radially contracted condition. The pleats can bebiased by spring elements.

In accordance with another aspect, the invention is directed to a spinalimplant having an elongated body dimensioned and configured to functionas a spacer, for placement in a target interspinous process space,between two adjacent spinous processes, the body having a tapered headportion, configured to gradually distract the two adjacent spinousprocesses during insertion therebetween, a distal anchor associated witha distal end of the body, the distal anchor having a plurality ofdeployable blades adapted to engage a first side of the two adjacentspinous processes, and a proximal anchor mounted for longitudinalmovement along the body between a first position spaced apart from thehead and a second position approximated with the head, adapted to engagea second side of the two adjacent spinous processes. Alternatively, thebody can maintain distraction performed by another instrument, prior toinsertion of the implant.

In accordance with still another aspect, the invention is directed to amethod of percutaneously performing interspinous process decompression,comprising the steps of providing a spinal implant having an elongatedbody dimensioned and configured to function as a spacer, for placementin a target interspinous process space, between two adjacent spinousprocesses, a distal anchor associated with a distal end of the body, anda proximal anchor mounted for longitudinal movement along the bodybetween a first position spaced apart from the head and a secondposition approximated with the head, adapted to compress the twoadjacent spinous processes, in conjunction with the distal anchor,forming an incision in a patient's skin, lateral from a targetinterspinous process space, in which the implant is to be placed,inserting a stylet through the incision, laterally to the targetinterspinous process space, using an internal imaging technique, to forman entry path, inserting one or more dilators, sequentially, along theentry path to dilate soft tissues between the incision and the targetinterspinous process space, inserting a sleeve through the entry path,selecting an implant having a size appropriate for a desired amount ofinterspinous distraction, inserting the implant, held by an insertiondevice, through the sleeve, up to the target interspinous process space,and advancing the implant into the interspinous process space.

In accordance with the invention, after the step of inserting thesleeve, a tap can be used. The tap can be a graduated-type tap, thediameter of which increasing toward the proximal end thereof. Duringrotation of such a tap, threads are cut into the adjacent spinousprocesses. If the tap is graduated, the adjacent spinous processes aregradually mutually distracted during advancement of the tap. Further,based on the distance the tap advances through the target interspinousprocess space, the surgeon can determine the size of the implant toinsert. In such an arrangement, the subject implant maintainsdistraction performed by the tap, and does not necessarily performdistraction.

The advancing step can include rotating the implant along a longitudinalaxis thereof, to effect axial advancement of the implant by way ofthreads formed on an outer surface thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

So that those skilled in the art to which the subject invention relateswill readily understand how to make and use the interspinous processimplant of the subject invention without undue experimentation,embodiments thereof will be described in detail herein below withreference to certain figures, wherein:

FIG. 1 is a perspective view of an interspinous process implant inaccordance with a first exemplary embodiment of the invention;

FIG. 2 is an exploded view of the implant of FIG. 1, illustrating thecomponents thereof;

FIG. 3 is a dorsal (rear) view of the implant of FIGS. 1-2, illustratingthe implant during installation into a target interspinous processspace, prior to compression of a distal end portion thereof;

FIG. 4 is a dorsal view of the implant of FIGS. 1-2, illustrating theimplant during installation into a target interspinous process space,during compression of the distal end portion thereof;

FIG. 5 is a dorsal view of the implant of FIGS. 1-2, illustrating theimplant in final position in the target interspinous process space, witha proximal anchor urged distally engaging a proximal surface of adjacentspinous processes, and the proximal end portion engaging distal surfaceof the adjacent spinous processes;

FIG. 6 is a cross-sectional view of the implant of FIG. 1, taken alongline 6-6 of FIG. 1, illustrating details of the distal end portionthereof;

FIG. 7 is a perspective view of an interspinous process implant inaccordance with a second exemplary embodiment of the invention, showingdistal anchor elements in a stowed position;

FIG. 8 is a perspective view of the implant of FIG. 7, showing thedistal anchor elements in a deployed condition;

FIG. 9 is an exploded view of the implant of FIGS. 7-8, illustrating thecomponents thereof;

FIG. 10 is a dorsal (rear) view of the implant of FIGS. 7-9,illustrating the implant during installation into a target interspinousprocess space;

FIG. 11 is a dorsal view of the implant of FIGS. 7-9, illustrating theimplant during installation, advanced to a position where distal anchorelements are unobstructed by anatomy, to allow for deployment thereof;

FIG. 12 is a dorsal view of the implant of FIGS. 7-9, illustrating theimplant during installation, with the distal anchor elements in adeployed condition;

FIG. 13 is a dorsal view of the implant of FIGS. 7-9, illustrating theimplant with a proximal anchor element urged distally, causingengagement of the implant with the adjacent spinous processes;

FIG. 14 is a perspective view of an interspinous process implant inaccordance with a third exemplary embodiment of the invention,illustrating distal anchor elements in a stowed position;

FIG. 15 is a perspective view of the implant of FIG. 14, illustratingthe distal anchor elements in a deployed condition;

FIG. 16 is a rear exploded view of the implant of FIGS. 14-15;

FIG. 17 is a front exploded view of the implant of FIGS. 14-15;

FIG. 18 is a cross-sectional view of the implant of FIGS. 14-15 taken atline 18-18 of FIG. 14, where the distal anchor elements are in a stowedposition;

FIG. 19 is a cross-sectional view of the implant of FIGS. 14-15 taken atline 19-19 of FIG. 15, where the distal anchor elements are in adeployed position;

FIG. 20 is a perspective view, illustrating an implant in preparation tobe installed dorsally, illustrated with the implant of FIGS. 14-15 butapplicable to all embodiments of the invention;

FIG. 21 is a dorsal view of an implant within an introducer tube duringlateral insertion thereof, illustrated with the implant of FIGS. 14-15but applicable to all embodiments of the invention;

FIG. 22 is a dorsal view illustrating the implant of FIGS. 14-15,showing the implant being screwed into a target interspinous processspace;

FIG. 23 is a dorsal view illustrating the implant of FIGS. 14-15,showing the implant with internal plunger urged distally, effectingdeployment of the distal anchor elements; and

FIG. 24 is a dorsal view illustrating the implant of FIGS. 14-15,showing the proximal anchor element urged distally, engaging theadjacent spinous processes.

DETAILED DESCRIPTION

With reference to FIGS. 1-6, there is illustrated an interspinousimplant constructed in accordance with a preferred embodiment of thesubject invention and designated generally by reference numeral 10. Theimplant 10 is particularly well adapted for use in performing minimallyinvasive surgical procedures for treating spinal stenosis, including,for example, interspinous process decompression (IPD).

It is envisioned however, that the implant 10 of the subject inventioncan be used in other spinal procedures as well, including, but notlimited to as an adjunct to spinal fusion procedures, or as a spinalstabilization device. Those skilled in the art will readily appreciatefrom the following description that the interspinous process implant ofthe subject invention is well adapted for percutaneous insertion, andthus overcomes many of the drawbacks of prior art devices presently usedin IPD procedures. That is, the implant 10 is dimensioned and configuredfor introduction and placement through a small skin incision rather thanin an open surgical procedure involving a cut down of tissue, as will bedescribed in more detail hereinbelow.

The interspinous process implant 10 includes an elongated threaded bodyportion 12 which can be configured as a solid element or alternativelycan be at least partially hollow, and which may include a plurality oflongitudinal openings 14 to permit insertion of demineralized bone oranother type of osteogenesis-promoting substances or fusion adjunctmaterial, and also promote the ingrowth of bone. The implant 10 furtherincludes a tapered or conical head portion 16, which is associated witha distal end of the body portion 12. The head portion 16 can bedimensioned and configured to progressively distract two adjacentspinous processes 381 a and 381 b as the implant 10 is advancedtherebetween. It is to be understood, however, that the head portion 16facilitates insertion of the implant, when distraction is initiallyperformed by a separate instrument. It is also to be understood that theelongated body portion 12 can alternatively be provided without threads,in accordance with an alternative aspect of the invention.

The head portion 16, and with other embodiment set forth herein, tapersaxially inwardly, by an angle between about 5 degrees and about 65degrees, with respect to a longitudinal axis of the implant 10. Inaccordance with one aspect of the invention, this angle is between about15 and about 45 degrees. In accordance with another aspect of theinvention, this angle is between about 25 and about 35 degrees. Inaccordance with still another aspect of the invention, this angle isabout 30 degrees. It is to be understood however, that this angle is notlimited to the foregoing ranges.

The head portion 16 can be attached to the body portion in any suitablemanner, including mechanical fasteners, mechanical interlock, welding orthe like. In the illustrated embodiment, an axial screw element isprovided, although an internal threaded connection can be provided, forexample.

The tapered head 16 of implant 10 includes a distal anchor portionconfigured as a trailing skirt section 18. The skirt section 18, asembodied, is a dynamic structure formed from a plurality ofcircumferentially spaced apart pleats 20. The pleats 20 can be hinged,and generally arcuate in configuration. Hinging can be accomplished byway of a defined line of weakness in the material, so as to form a“living hinge,” or alternatively can be a conventional hinge with aseparate pivot. Alternatively still, the necessary deflection of thepleats 20 can be accomplished without a defined hinge, utilizing onlythe cumulative bending of the pleats 20 along their length. Further, thepleats 20 can be embodied in shapes other than those having an arcuateconfiguration, such as a generally rectangular parallelepiped, forexample.

In accordance with one preferred aspect, the head portion 16 andtrailing skirt section 18 have helical threads 22 so as to easeprogressive advancement of the head portion 16 and skirt section 18between the two adjacent bony spinous processes 381 a and 381 b duringinsertion therethrough. When applied with a rotational force duringinsertion, the threads 22 serve to draw the implant 10 into the targetinterspinous process space 382, defined by the adjacent spinousprocesses 381 a, 381 b. It is envisioned that the helical threads 22 canbe any of a variety of suitable forms, such as, for example, cuttingthreads or box threads. However, it is also envisioned and well withinthe scope of the subject disclosure that the tapered head portion 16 andskirt section 18 can be provided without any threads. Further, anintegral tap chamfer can be incorporated into the threads, ifso-desired. In embodiments in which no threads are provided, the headportion 16 of the implant 10 can be advanced between the two adjacentspinous processes 381 a and 381 b by application of a generally axiallydirected force.

As best seen in FIG. 6, each of the arcuate pleats 20 of the skirtsection 18 are biased into a radially expanded condition shown in FIG. 1by coiled biasing springs 25. The coiled biasing springs 25 aresupported on guide pins 26 that are retained in body portion 12 by heads28. The heads 28 of the guide pins 26 act to limit the extent to whichthe arcuate pleats 20 of skirt section 18 can extend. It is envisionedthat alternative biasing mechanisms can be used to bias the pleats 20into an expanded condition, including but not limited to a provision ofelastic material, such as an elastomer. Such a material can be abio-compatible silicone, for example. As explained in more detail below,the pleats 20 are adapted and configured for movement between a (first)radially expanded condition shown in FIGS. 1-3 and 5 and a (second)radially compressed condition shown, for example, in FIG. 4. If desired,a sheath (not illustrated) can be provided over the structure of thehead portion 16, such as a thin layer of a biocompatible elastomer, tomaintain a continuous surface while permitting flexibility between thepleats. Alternatively, webs or similar elements can be provided betweenadjacent pleats 20. The implant device 10 further includes a proximalanchor portion 30 that is operatively associated with the threaded body12 in such a manner so as to enable the longitudinal movement of theanchor portion 30 along the length of body 12 between a first position,spaced from the head portion 16 (e.g., FIG. 3) and second position,approximated with the head portion 16 (e.g., FIG. 5). It is envisionedthat the operative connection between the body portion 12 and theproximal anchor 30 can be accomplished in a variety of ways including adirect threaded engagement between the proximal anchor 30 and the body12 or through the use of a captured threaded nut that permits theproximal anchor 30 to translate longitudinally along the threaded bodyportion 12 without rotating about the axis of the body portion 12, suchas by providing one or more interfacing flat regions 17 a, 17 b.

With reference to FIGS. 1-6, the proximal surfaces of the arcuate pleats20 of the trailing skirt section 18 can be provided withproximally-directed spikes 24 adapted and configured to engage the bonyanatomy of the spinous processes 381 a and 381 b, when the head portion16 and the anchor portion 30 are mutually approximated about the spinousprocesses 381 a and 381 b. Similarly, the distal surface of the proximalanchor 30 can include a plurality of circumferentially spaced, distallyfacing spikes 34 for engaging the bony spinous processes 381 a and 381 bwhen the head portion 16 and the anchor portion 30 are mutuallyapproximated into the position shown in FIG. 5. The spikes 34, or anyspikes described herein in connection with any embodiment of theinvention are not limited to any particular shape, but can be generallyconical, pyramidal or tetrahedral, for example. Alternatively, thespikes can be truncated versions of such shapes.

In use, as the head portion 16 is inserted between the two adjacentspinous processes 381 a and 381 b, as shown in FIG. 4, the pleats 20 ofthe skirt section 18 are urged into a compressed condition, against thebias of the coiled springs 25, or alternative biasing elements. Inaccordance with the invention, the pleats 20 can compress so as to notextend beyond the diameter of the body 12, if necessary. Once the skirtsection 18 is beyond the distracted spinous processes 381 a, 381 b, thepleats 20 are urged back into their normally expanded position under thebias of the springs 25. The implant 10, alternatively, can be insertedfollowing insertion of a separate instrument, such as a tap or otherdistractor, in which case the implant 10 does not necessarily causedistraction during insertion thereof, but rather maintains distraction.

In accordance with another aspect of the invention, the head portion 16can be provided and inserted in a collapsed state, and expanded when theimplant 10 is placed in the desired position. Expansion of the headportion 16 can be achieved by way of an internal cam mechanism, asdescribed in connection with the embodiments described below. In such anarrangement, an outwardly biasing member can be eliminated, while theheads 28 of the guide pins 26 follow an internal moveable cam, forexample. It may be desirable in such an arrangement to provideinwardly-biasing elements (e.g., springs placed within the body 12,between the body 12 and the pin heads 28, if the structure of the headportion 16 alone is not sufficient to maintain a collapsed condition ofthe head portion 16. The reader will appreciate that any implantconstructed in accordance with the invention can be provided in anormally deployed condition, or a normally collapsed condition.

Thereafter, the proximal anchor 30 is moved into approximation with thehead portion 16, as shown in FIG. 5. Once approximated, the head portion16, having a distal anchor composed of the pleats 20, and the proximalanchor 30 compress the spinous processes 381 a and 381 b therebetweenand the spikes 24, 34 on each component secure the implant 10 againstunintentional migration. The resulting construct serves to stabilizespinous processes 381 a, 381 b of the target interspinous process space382, while at the same time the body portion 12 acts as a spacer betweenthe spinous processes 381 a and 381 b to decompress tissues between therespective adjacent vertebrae.

The body 12, as with any of the other embodiments described herein canbe provided with the following dimensions, but are not limited thereto.The body portion 12 is dimensioned and configured for threaded placementbetween the spinous processes of symptomatic disc levels. In thisregard, it is envisioned that the outer diameter of the implant 10 canrange from about 8.0 mm to about 16.0 mm, with the thread depth beingabout 1.0 mm. The threads on the body portion 12 of the implant 10 canbe configured so that the implant is self-tapping to ease insertion ofthe implant into the interspinous process space, as described below. Asmentioned, the implant 10, as with any implant in accordance with theinvention, can be provided with or without threads, as desired orrequired.

The components of the implant 10, or any implant constructed inaccordance with the invention can be formed out of similar or identicalmaterials to one another. For example, polymeric materials, such asPEEK, alloys, such as titanium alloys or shape-memory alloys, such asNitinol, ceramic and/or composite materials can be used, as desired orrequired. However, it is specifically envisioned that the components ofthe implant 10 can be formed from different materials from one another.For example, the body 12 can be formed from a polymeric material, suchas PEEK, while the head portion can be formed of an alloy, such as atitanium alloy or a shape-memory alloy, such as Nitinol. Ceramic and/orcomposite materials can additionally or alternatively be used, asdesired or required.

Referring now to FIGS. 7-13, there is illustrated another embodiment ofthe implant of the subject invention, which is designated generally byreference numeral 100. Implant 100 is similar to the previouslydescribed implant 10 in that it includes an elongated threaded bodyportion 112, a tapered head portion 116 at the distal end of the bodyportion 112 and a proximal anchor portion 130 adapted for longitudinalmovement along the length of the body portion 112 between a firstportion spaced from the head portion 116 and a second positionapproximated with the head portion 116.

Implant 100 differs from implant 10 in the manner in which the distalend portion thereof engages the adjacent anatomy (spinous processes 381a, 381 b). In accordance with one aspect, instead of having a pluralityof outwardly biased pleats (20) as a distal anchor portion, the headportion 116 includes a plurality of circumferentially spaced apartdeployable blades 120 that are mounted for pivotal movement about apivot ring 123, within a bore 150 of the implant 100. In particular, theblades 120 are mounted for movement between a first, stowed positionshown in FIG. 7, retracted within the head portion 116 and a second,deployed position shown in FIG. 8, projecting radially outwardly fromthe head portion 116. The body 112 of the implant 110 is provided withapertures 115, corresponding to each blade 120 provided.

Movement of the blades 120 between the retracted and deployed positionsis accomplished, at least in-part, through actuation by an internalplunger 126. More particularly, the surfaces of the head 128 of theplunger 126 act as a cam, and cooperate with inner cam surfaces 140formed on each of the blades 120. As the plunger head 128 movesdistally, cam surfaces 140 of the blades 120 follow the outer surface ofthe plunger head 128, and urge the blades 120 radially outwardly.

As illustrated, four orthogonal blades 120 are provided, although it isto be understood that any practicable number thereof can be provided,including but not limited to a total of one, two, three, four, five,six, seven, eight, nine or ten blades 120, for example.

The blades 120 and their annular pivot ring 123 are mutually connectedwithin the bore 150 of the body 112, thus forming a subassembly 119. Thesubassembly 119 can be provided in an axially fixed location along thelongitudinal axis of the implant 100, or alternatively can be configuredto permit limited axial movement of the subassembly 119.

In one aspect, the blades 120 are fitted to the pivot ring 123, which isin-turn, positionally constrained to, or alternatively integrally formedwith, the inner wall 152 of the bore 150. Securement of the axialposition of the pivot ring 123 to the wall 152 can be facilitated in anysuitable fashion, which may depend on the precise material selection.Mechanical connections can be utilized, for permitting snap or pressfitting thereof, for example. For example, one or more stops in the formof protrusions, or alternatively grooves 154, can be provided in thebore 150. With such features, the pivot ring 123 can be captured and itsaxial position fixed. In this regard, the pivot ring 123 can beconfigured as a “split ring” or as an otherwise circumferentiallycompressible member. As such, the subassembly 119 can be insertedaxially from the proximal end 117 of the body 112, through the bore 150,and moved toward the distal end of the implant 100. Such engagement canbe either permanent or temporary, depending on the preciseimplementation thereof. Alternatively or additionally, to achievepermanent positioning, the ring 123 can be permanently attached, such asby welding, to the inner wall 152 of the bore 150, provided thatcompatible materials are used.

If repositionability of the subassembly 119 is desired, the relativesize and configuration of protrusions and/or grooves can be such thatthe pivot ring 123 is releasably captured by such features (e.g., groove154), and can be removed therefrom upon application of sufficient force.In this regard, the pivot ring 123 includes inherent mechanicalproperties including elasticity or stiffness (i.e., spring rate),frictional properties and the like, which depend on the material beingused. If dimensioned and implemented suitably, the subassembly 119,including the blades 120 and the pivot ring 123 can be axiallypositioned at any stage by way of such a feature.

As shown in FIG. 7, the blades 120 can be stowed prior to placement ofthe implant 100. To inhibit unintended pivoting of the blades 120 aboutthe pivot ring 123, which could interfere with the insertion process, astowed configuration of the subassembly 119 can permit the radiallyouter ends 132 thereof to be rotated inward, through the apertures 115,and into the bore 150 of the implant 100. The subassembly 119 can thenbe moved proximally, bringing the blades 120 fully within the bore 150,and capturing their radially outer ends 132 within the bore 150. Apositioning feature, such as a groove (e.g., 154) for example, cancorrespond with this stowed position and maintain the axial position ofthe subassembly 119 until deployment of the blades 120 is desired. Atthat time, the plunger 126 can be urged distally, pushing thesubassembly 119 to an axial position in which the blades 120 are free torotate about the pivot ring 123 and through the apertures 115, which canbe accomplished by way of movement of the plunger 126 in connection withthe cam surfaces 140 of the blades 120, as described above.

Optionally, the subassembly 119 can be configured to travel axially tothe distal end of the bore 150, at which position the outer surfaces ofthe blades 120 abut the inner end face 152 of the bore 150. Suchpositioning advantageously inhibits eversion or overextension of theblades 120 from a deployed position in which they are configured toengage the target spinous processes 381 a, 381 b (e.g., FIGS. 10-13).

In configurations in which the subassembly 119 of the blades 120 andpivot ring 123 are axially moveable, the head 128 of the plunger 126 canbe figured with an outer diameter that is greater than an inner diameterof the pivot ring 123, so that actuation of the plunger 126 yieldsdistal axial translation of the subassembly 119, simply by pushingagainst it, following rotation of the blades 120 outward, radially.

In accordance with the invention, one or more linear pivots can beprovided in lieu of the pivot ring 123. Such linear pivots can beprovided as stationary elements, secured to or through the body 112, oralternatively can be mounted for axial movement with respect to the body112. Such linear pivots can be mounted tangentially or transversely,with respect to the body 112, or can be centrally mounted (e.g.,transverse to and intersecting the longitudinal axis of the body 112).

The plunger 126 itself can be provided with various features, includingfeatures to permit actuation thereof, and secure positioning thereof.For example, as best illustrated in FIG. 9, the plunger 126, in additionto the distal rounded head 128, can include a proximal head 125 having aproximal internal recess 121, and an angled distal surface to facilitatedistal-directed urging and proximal-directed urging, respectively,applied from the proximal direction. The plunger 126 can also include arecess 129, for securely engaging a resilient catch 127. The catch 127is configured to interface between the plunger 126 and internal surfacefeatures of the body 112, such as annular grooves or recesses. Asdescribed, the resilient catch 127 permits axial movement of the plunger126, and in conjunction with the above-described internal surfacefeatures of the body 112, defined positions at which the plunger 126 isheld, inhibiting unintentional movement therefrom. The catch 127 can beformed of any suitable material or configuration, such as from aresilient material, such as an elastomer, or as a resilient structure,such as a toroidal metallic coil, or a combination of these, forexample. In the illustrated embodiment, as best seen in FIGS. 9, 12 and13, the plunger 126 is overmolded with an elastomeric material. In thesubsequent embodiment, a more discrete element is provided, whichconfiguration can equally be applied to this embodiment.

As shown in FIGS. 7-13, the implant 100 is also similar to implant 10 inthat the distal surface of the proximal anchor 130 can include aplurality of distally facing spikes 134 for engaging one side of thespinous processes 381 a, 381 b adjacent to the target interspinousprocess space 382 (FIGS. 10-13). In a similar fashion, the proximalfacing surfaces of the blades 120 can be furnished with spikes 124 forengaging the other side of the spinous processes 381 a, 381 b.

FIGS. 10-13 illustrate various stages during insertion and placement ofthe implant 100. FIG. 10 is a dorsal (rear) view of the implant 100illustrating the implant during installation into a target interspinousprocess space 382. FIG. 11 is a dorsal view of the implant 100,illustrating the implant 100 during installation, advanced to a positionwhere distal anchor elements or blades 120 are unobstructed by anatomy,allowing for deployment thereof. FIG. 12 is a dorsal view of the implant100, illustrating the implant 100 during installation, with the distalanchor elements 120 in a deployed condition. FIG. 13 is a dorsal view ofthe implant 100, illustrating the implant 100 with the proximal anchor130 urged distally, causing engagement of the implant 100 with theadjacent spinous processes 381 a, 381 b.

In accordance with the invention, as discussed above in connection withthe embodiment of FIGS. 1-6, the implant 100 can be inserted into atarget interspinous process space 382 with the blades 120 alreadydeployed, extending outwardly from the body 112. For example, in suchapplication, the plunger 126 is placed in a distal position where theblades 120 are deployed. The plunger 126 can be placed in a partlyextended (intermediate) position, or in a fully extended position. In apartly extended position, radially-inward urging of the blades 120causes proximal urging of the plunger 126. The plunger 126, therefore,can be provided with a stop or as spring-biased to a distal orintermediate position. If spring-biased distally, the plunger 126 willthen attempt to urge the blades 120 outwardly once they are free frominterference. Alternatively still, the implant 100 can be embodied suchthat the pivot ring 123, or other pivot arrangement, permits inwardurging of the blades 120 despite placement of the plunger 126 in itsfully extended position. In such an arrangement, the blades 120 pivotabout the head 128 of the plunger 126, as the pivot ring 123 flexes topermit the ends 132 of the blades 120 to move inwardly.

FIGS. 14-24 illustrate an interspinous process implant 200 in accordancewith a further aspect of the invention. The implant 200 includes certainfeatures of the foregoing embodiments, where similar elements aredesignated with similar reference numbers as used above. The implant 200includes a body 212, providing overall structure to the implant 200. Thebody 212, as illustrated, is provided with threads 222 for facilitatinginsertion of the implant 200 into a target interspinous process space382 (FIGS. 20-24), as will be described in more detail below inconnection with FIGS. 20-24, as well as for providing additionalengagement with the anatomy of the patient in the target interspinousprocess space 382. Further, the threads 222 permit rotational engagementbetween the body 212 and a proximal nut 235, provided to securely engagethe implant 200 with interspinous processes 381 a, 381 b adjacent thetarget interspinous process space 382, which will be described in moredetail below. Alternatively, this implant 200, and the other implants10, 100 of the invention can be provided without threads thereon, orwith threads provided only on a portion thereof for one of the foregoingfunctions. That is, if desired, threads 222 can be provided only on theproximal end of the body 112, for engaging the nut 235 and not on thedistal portion, or vice versa.

As with the foregoing embodiments, a distal anchor portion is provided,and in this embodiment is configured as two opposed deployable blades220 (220 a, 220 b). The blades 220 are provided with a common pivot,defined by a pin 259 passing therethrough, as well as through the body212. Use of a common pivot advantageously minimizes the space requiredfor housing all elements within the body 212 in their stowed state,although variations from this precise configuration are possible. Forexample, two separate pivots can be provided for each blade 220 a, 220b, still in keeping with the invention. The blades 220, as illustrated,are provided with proximally directed spikes 224 for engaging therelevant adjacent bony anatomy, such as the spinous processes 381 a,381b. The blades 220 can alternatively be provided without such spikes 224.

The blades 220 a, 220 b are respectively provided with hinge portions223 a, 223 b for engaging the pin 259. In the illustrated embodiment,one hinge portion 223 a is shaped as a clevis, while the other 223 b isshaped to fit within the clevis-shaped hinge portion 223 a. In theillustrated embodiment, a plunger 226 is provided and includes a headportion 228 shaped and configured to act as a cam and cooperate withinner cam surfaces 240 formed on each of the blades 220 a, 220 b, asdescribed above. As the plunger head 228 moves distally, cam surfaces240 of the blades 220 a, 200 b follow the outer surface of the plungerhead 228, and urge the blades 220 a, 220 b radially outwardly. Inaddition, the plunger can include, as described above, a proximal head225 having a proximal internal recess 221, and an angled distal surfaceto facilitate distally-directed urging and proximal-directed urging,respectively, applied from the proximal direction. The plunger 226 canalso include a recess 229, for securely engaging a resilient catch 227.The catch 227 is configured to interface between the plunger 226 andinternal surface features of the body 212, such as annular grooves orrecesses 254. As described, the resilient catch 227 permits axialmovement of the plunger 226, and in conjunction with the above-describedinternal surface features of the body 212, defined positions at whichthe plunger 226 is held, inhibiting unintentional movement therefrom.The catch 227 can be formed of any suitable material or configuration,such as from a resilient material, such as an elastomer, or as aresilient structure, such as a toroidal metallic coil, or a combinationof these, for example. The catch 227 can be, in accordance with theinvention, a canted coil, such as a Bal Latch™, available from Bal SealEngineering, Inc. of Foothill Ranch, Calif., USA.

When deployed, the blades 220 function in concert with the proximalanchor portion 230, which is axially moveable along the length of theimplant 200. The nut 235 includes threads on its inner surface thatengage the threads 222 provided on the outer surface of the body 212.Accordingly, rotational movement of the nut 235 yields axial movementthereof. When that axial movement is in the distal direction, the nut235 urges the proximal anchor portion 230 distally until it abuts thebony structures (e.g. spinous processes 381 a, 381 b) surrounding thetarget interspinous process space 382. If provided, protrusions orspikes 234 on the proximal anchor portion facilitate engagement with thebone and thus stabilization of the entire vertebrae-implant construct.

As illustrated, opposed flat portions 217, comprising upper and lowerflat portions 217 a, 217 b, respectively, guide correspondingly shaped(e.g., flat) portions 237 of the proximal anchor 230, permitting axialmovement but inhibiting rotational movement thereof, during movement ofthe nut 235. A lock washer 233 or equivalent feature can be provided toinhibit unintentional loosening of the nut 235 following implantationand deployment of the blades 220 a, 220 b.

With reference to the cross-sectional views of FIGS. 18-19, in theillustrated embodiment, the blades 220 can be provided with an internalspring element 281, spanning between respective recess in each of theblades 220 a, 220 b. The spring element 281 can be provided straight tomaintain the blades 220 a, 220 b deployed (open) normally, oralternatively, bent, to maintain the blades 220 a, 220 b stowed(contracted) normally. In accordance with one aspect, the spring element281 is provided bent, and urges the blades 220 a, 220 b inwardly, towardthe stowed position, prior to and during implantation. Thus, inconnection with the plunger 226, the spring 281 serves to maintain aposition of the blades 220. As illustrated, when the plunger 226 isfully extended, a head portion 228 thereof engages a correspondingdetent 249 in the profile 240 of the blades 220 a, 220 b. The engagementof the detent 249 by the head portion 228 further ensures securedeployment of the blades 220 a, 220 b.

In accordance with the invention, the spring element 281 canalternatively be provided as normally straight, urging the blades 220 a,220 b outwardly toward the deployed position, prior to, during andfollowing implantation. During implantation, however, the spring element281 permits inward rotation of the blades 220 a, 220 b, temporarilybending the spring element 281 in the process. Thus, during implantationthe spring 281 serves to maintain a position of the blades 220 a, 220 bagainst externally-applied forces. Once placed in the targetinterspinous process space 382, the plunger 226 can be urged distally inorder to lock the blades 220 a, 220 b in the deployed position.Engagement of the detent 249 by the head portion 228 of the plunger 226further ensures maintenance of that position. The body 212 includes atits proximal end, an expanded-diameter portion 213, defining aproximal-most limit for traveling of the nut 235 and proximal anchor230. Also in the proximal end portion, formed within the bore 250, is ashaped socket 251 for engagement with an insertion tool. As illustrated,the socket 251 is substantially hexagonal, with flat portions defined atregular angular intervals. Practicable departures from the preciseconfiguration illustrated are possible. The shaped socket 251facilitates mutual rotational engagement between the implant 200 and theinsertion tool. Also provided in connection with the socket 251, aretransverse grooves 253, which, in conjunction with a correspondingelement on the insertion tool, inhibit unintentional mutual axialdisplacement therebetween. The corresponding element on the insertiontool can be, for example, a resiliently and optionally lockableprotrusion extending laterally (i.e., radially) from the insertion tool.The lockable protrusion may be, for example, a lockable spring-loadedspherical element, for example.

As with foregoing embodiments, the implant 200 can be provided with oneor more apertures 214 to permit packing of the implant, such as in thebore 250 thereof, with osteogenesis-promoting substances to facilitatebone ingrowth and/or fusion, such as demineralized bone.

FIGS. 20-24 illustrate various stages during insertion and placement ofthe implant 200 into a target interspinous process space 382. In short,FIG. 20 is a perspective view of the implant 200, in preparation to beinstalled dorsally through a curved introducer tube 387, which has beeninserted through an incision 389 formed through the skin 388 of apatient. FIG. 21 is a dorsal (rear) view of the implant 200, held by anelongate insertion tool 392, within a lumen of an introducer tube 397,during lateral insertion thereof. FIG. 22 is a dorsal view illustratingthe implant 200, laterally advancing to the target interspinous processspace 382, under application of a rotational force applied by theinsertion tool 392, by virtue of the threads 222 provided on the body212 thereof. FIG. 23 is a dorsal view illustrating the implant 200 withthe internal plunger 226 urged distally, effecting deployment of thedistal anchor elements—in this case, blades 220 a, 220 b. The nut 235 isthen tightened, which urges the body 212 proximally, and thus also urgesthe blades 220 more securely against the adjacent bony structure,impinging the spinous processes 381 a, 381 b therebetween, as shown inFIG. 24, which is a dorsal view illustrating the implant 200 with theproximal anchor element 230 urged distally by the nut 235, engaging theadjacent spinous processes 281 a, 281 b.

More particularly, as seen in FIG. 20, a sleeve 387 is provided tofacilitate insertion. The insertion methods can include use of a stylet,dilators, and the like to gain access and define a path for the sleeve387, as will be described in more detail below. However, dorsalinsertion can be accomplished as set forth in U.S. patent applicationSer. No. 12/011,905, filed Jan. 30, 2008 (U.S. Pub. No. 2009/0054988),which is incorporated herein by reference in its entirety.

As illustrated, in FIG. 20, dorsal insertion of the subject implants,represented by implant 10, can be effected by forming an incision 389through the skin 388 of a patient, at a level corresponding to a targetinterspinous process space 382, defined between adjacent vertebralprocesses 381 a, 381 b. With dorsal entry illustrated in FIG. 20, thepath traversed by the implant 200, and therefore also by the sleeve 387is curved to align the path and the implant 200 with the targetinterspinous process space 382.

FIG. 21, in contrast, illustrates direct lateral insertion of theimplant 200 into the target interspinous process space 382. In thisarrangement, an incision 399 is formed in the skin 388 of a patient, andultimately a sleeve 397 is advanced through the tissue to the targetinterspinous process space 382, through which the implant 200 isadvanced, connected to the insertion device 392. As shown in FIGS.22-24, which are illustrated for clarity without the sleeve 397, theimplant 200 is axially rotated by way of the insertion device 392, thusthreading the implant 200 into the target interspinous process space382, distracting the adjacent spinous processes 381 a, 381 b, andadvancing the implant 200 into its final position, generally centeredwith respect to the spinous processes 381 a, 381 b. As set forth above,distraction can be performed in advance by a separate instrument, withinsertion of the implant following, and maintaining such distraction.During the rotation of the implant 200, relative rotation and axialtranslation between the implant 200 and the insertion device 392 ispreferably inhibited by the above-mentioned features. When in position,the anchoring blades 220 a, 220 b can be deployed, as shown in FIG. 23.Subsequently, the nut 235 can be tightened, advancing the lockingproximal anchor 230 distally into engagement with the spinous processes381 a, 381 b.

Subsequently, one or more osteogenesis promoting substances can bepacked in and/or around the implant 200 to promote bone ingrowth and/orspinal fusion, if desired.

A separate tap can be used in the target interspinous process space 382before the insertion of the implant 200, or as mentioned above, theimplant 200 can be provided with features that provide self-tappingcapability.

Methods of lateral insertion of the spinal implant 200 into a targetinterspinous process space 382 can include, following forming theincision 399, inserting a stylet (not illustrated) through the incision399, laterally to the target interspinous process space 382, preferablyusing an internal imaging technique, such as fluoroscopy.

Insertion of the stylet forms an entry path, along which one or moredilators can be sequentially advanced, in order to dilate soft tissuesbetween the incision and the target interspinous process space 382. Thesleeve 397 can then be advanced through the entry path. After insertingthe sleeve 397, a distractor, which can be a tap (e.g., a graduatedtap), can then be inserted and advanced into the target interspinousprocess space 382, to tap and gradually distract the adjacent spinousprocesses 381 a,381 b and/or help determine an appropriate size ofimplant to be inserted.

Following selection of an implant 200 having a size appropriate for adesired amount of interspinous distraction, the implant 200 can beinserted, held by the insertion device 392, advanced through the sleeve397, up to the target interspinous process space 382, after which theimplant 200 can be inserted into the target interspinous process space382. In the case of threaded implants, rotational motion is applied toadvance the implant 200 and, if not already distracted, to distract theadjacent spinous processes 381 a, 381 b. In the case of non-threadedimplants, laterally-directed pressure can be applied until the implant300 is in the desired position, after which any proximal and/or distalengagement elements can be deployed.

Many of the primary structural components of the implant devicesdescribed herein are preferably formed from biological and/orbiocompatible materials, including metal, ceramic, polymeric and/orcomposite materials that can be selected to have a modulus of elasticitythat is substantially similar to that of bone, for example,polyetheretherketone thermoplastic (PEEK), machined bone, a titaniumalloy or stainless steel, for example.

While the apparatuses and methods of subject invention have been shownand described with reference to preferred embodiments, it is to beunderstood that any feature described in connection with one embodimentcan be advantageously applied to other embodiments of the invention,even if not explicitly described in connection therewith, if suchfeature(s) are not mutually exclusive with other features of suchembodiment. Nevertheless, those skilled in the art will readilyappreciate that further changes or modifications may be made to devicesand methods of the present invention without departing from the spiritand scope thereof.

1-21 (canceled)
 22. A spinal implant comprising: a) an elongated bodydimensioned and configured to function as a spacer, for placement in atarget interspinous process space, between two adjacent spinousprocesses and having a longitudinal axis extending therethrough; b) adistal anchor associated with a distal end portion of the body forengaging adjacent spinous processes including two radially deployableblades adapted to engage two adjacent spinous processes wherein the tworadially deployable blades are mounted to transition from a stowedposition within an internal chamber of the elongated body and a deployedposition projecting radially outward; and c) a proximal anchor mountedfor longitudinal movement along the body between a first position spacedapart from the distal end portion of the body and a second positionapproximated with the distal end portion of the body, the proximalanchor adapted to engage the two adjacent spinous processes inconjunction with the distal anchor, wherein the proximal anchor includesan axially slideable plate and a nut for axial movement of the proximalanchor by rotational movement of the nut.
 23. The spinal implant ofclaim 22, wherein the axially slideable plate is between the nut and thedistal anchor axially, and wherein a threaded outer surface of the bodyincludes at least one flat portion engaged with a corresponding flatportion formed in a central hole of the axially slideable plate forinhibiting relative rotation of the axially slideable plate and thebody.
 24. The spinal implant of claim 22, wherein the distal anchorincludes a tapered head.
 25. The spinal implant of claim 24, wherein thetapered head has a plurality of circumferentially spaced apartproximally facing spikes for engaging the spinous processes when thehead and the anchor are approximated.
 26. The spinal implant of claim24, wherein the tapered head has a trailing skirt section adapted andconfigured for movement between a radially expanded condition a radiallycompressed condition as the head is inserted between the two adjacentspinous processes.
 27. The spinal implant of claim 24, wherein thetrailing skirt section of the head includes a plurality ofcircumferentially spaced apart hinged pleats that are biased into saidradially expanded condition.
 28. The spinal implant as recited in claim24, wherein the pleats are biased by spring elements.
 29. The spinalimplant as recited in claim 24, wherein the internal chamber of theelongated body is packed with osteogenesis-promoting substancesconfigured to facilitate bone ingrowth and fusion.
 30. A spinal implantcomprising: a) an elongated body dimensioned and configured to functionas a spacer, for placement in a target interspinous process space,between two adjacent spinous processes, the body having a longitudinalaxis extending therethrough and a tapered head portion configured togradually distract the two adjacent spinous processes during insertiontherebetween wherein an outer surface of the body, including the taperedhead portion, is threaded; b) a distal anchor associated with a distalend portion of the body for engaging the two adjacent spinous processesincluding two radially deployable blades adapted to engage two adjacentspinous processes wherein the two radially deployable blades are mountedto transition from a stowed position within an internal cavity of theelongated body and a deployed position projecting radially outward; andc) a proximal anchor mounted for longitudinal movement along the bodybetween a first position spaced apart from the tapered head portion anda second position approximated with the tapered head portion, whereinthe proximal anchor includes an axially slideable plate for engaging thespinous processes.